Company ยท US
Rusch, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2001. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 10 |
| CBP | Valve, Non-Rebreathing | 5 |
| EZL | Catheter, Retention Type, Balloon | 2 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 |
| KOB | Catheter, Suprapubic (And Accessories) | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| BSR | Stylet, Tracheal Tube | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 1 |
| FPD | Tube, Feeding | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| NYT | Prosthesis, Tracheal, Expandable, Polymeric | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 2001 | K010420 | RUSCH MMG/O'NEIL CATHETER Rusch, Inc. | FCM |
| May 31, 2000 | K993528 | RUSCH EMERGENCY MASK Rusch, Inc. | CBP |
| Mar 24, 2000 | K993194 | RUSCH MANUAL RESUSCITATOR BAG Rusch, Inc. | BTM |
| Jun 9, 1998 | K980870 | RUSCH SILICONE FOLEY CATHETER Rusch, Inc. | EZL |
| Jan 27, 1998 | K974419 | RUSCH SIMPLASTIC COUNCILL TIP CATHETER Rusch, Inc. | EZL |
| May 23, 1997 | K963779 | RUSCH ENTERAL FEEDING TUBE Rusch, Inc. | FPD |
| Feb 7, 1997 | K970021 | RUSCH SUPRAPUBIC TRAY Rusch, Inc. | KOB |
| Dec 17, 1996 | K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET Rusch, Inc. | FCM |
| Jun 28, 1996 | K955564 | RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE Rusch, Inc. | JOH |
| Jun 27, 1996 | K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE Rusch, Inc. | BTR |
| Nov 27, 1995 | K953963 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION Rusch, Inc. | BTS |
| Nov 21, 1995 | K922567 | LOW PROFILE CATHETER Rusch, Inc. | KNT |
| Oct 13, 1995 | K953593 | RUSCH TRACHEAL BRONCHIAL Y STENT Rusch, Inc. | NYT |
| Aug 8, 1995 | K952100 | RUSCH ENDOTRACHEAL TUBE STYLET Rusch, Inc. | BSR |
| Jul 25, 1995 | K952187 | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE Rusch, Inc. | KOB |
| May 23, 1995 | K935842 | RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE Rusch, Inc. | BTR |
| Dec 3, 1993 | K922998 | ENFUSE ENTERAL FEEDING TUBE Rusch, Inc. | KNT |
| Sep 2, 1993 | K925508 | RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP Rusch, Inc. | BTR |
| Sep 2, 1993 | K925507 | RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP Rusch, Inc. | BTR |
| Sep 2, 1993 | K925505 | RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE Rusch, Inc. | BTR |
| Aug 2, 1993 | K925506 | RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE Rusch, Inc. | BTR |
| Jun 23, 1993 | K931164 | RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EY Rusch, Inc. | BTR |
| Jun 23, 1993 | K931163 | RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYE Rusch, Inc. | BTR |
| Jun 22, 1993 | K931166 | RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY Rusch, Inc. | BTR |
| Jun 22, 1993 | K931165 | RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE Rusch, Inc. | BTR |
| Apr 15, 1993 | K923003 | PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN. Rusch, Inc. | BSP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Rusch Inc One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, Terminated |
CBP | None listed |
| Jul 20, 2004 | Rusch Inc One Way Valve/Male to Female Flow, 22 mm I.D./22 mm O.D., Ref 396799, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, Terminated |
CBP | None listed |
| Jul 20, 2004 | Rusch Inc RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling Terminated |
CBP | None listed |
| Jul 20, 2004 | Rusch Inc 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling, except for, Terminated |
CBP | None listed |